Malignant Mesothelioma Clinical Trial
Official title:
A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma
The purpose of this study is to determine the response rate to the combination of doxorubicin and valproate acid in patients with MM failing after at least one previous chemotherapy regimen including platinum derivatives .
Status | Completed |
Enrollment | 45 |
Est. completion date | June 2010 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histological diagnosis of malignant mesothelioma - Unresectable or inoperable malignant mesothelioma failing after at least one prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin) - At least one evaluable or measurable CT-lesion - Availability for participating in the detailed follow-up of the protocol - Signed informed consent Exclusion Criteria: - Patients who are candidates for surgery with curative intent - Patient who were previously treated with anthracyclin derivatives - Performance status < 60 on the Karnofsky scale - A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval) - A history of prior HIV infection - Polynuclear cells < 2,000/mm³ - Platelet cells < 100,000/mm³ - Abnormal coagulation tests (aPTT, PTT, prothrombin time) and/or decreased fibrinogen - Serum bilirubin >1.5 mg/100 ml - Transaminases more than twice the normal range - Serum creatinine > 1.5 mg/100 ml - Recent myocardial infarction (less than 3 months prior to date of diagnosis) - Congestive cardiac failure (ejectional fraction of the left ventricle < 50%) or uncontrolled cardiac arrhythmia - Uncontrolled infectious disease - Active epilepsy needing a specific treatment - Concomitant treatment with IMAO, carbamazepine, mefloquine, phenobarbital, primidone, phenytoïn, lamotrigine, zidovudine - Pregnancy or refusal to use active contraception - A known allergy to valproate acid and/or doxorubicin - Serious medical or psychological factors which may prevent adherence to the treatment schedule |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Department of Pneumology CHR St joseph - Warquignies | Boussu | |
Belgium | Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet | Brussels | |
Belgium | Department of Pneumology Hôpital Ixelles-Molière | Brussels | |
Belgium | Department of Pneumology CHU Charleroi | Charleroi | |
Belgium | Department of Pneumology Hôpital Saint-Joseph | Gilly | |
Belgium | Hôpital Ambroise Paré | Mons | |
Belgium | CH Peltzer-La Tourelle | Verviers | |
France | Department of Pneumology CHRU Lille | Lille |
Lead Sponsor | Collaborator |
---|---|
European Lung Cancer Working Party |
Belgium, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | Every 3 courses | Yes | |
Secondary | Survival | Survival will be dated from the day of registration until death or last follow up | No | |
Secondary | Toxicity | After each course of chemotherapy and at the end of treatment | No |
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